FDA 510(k) Applications for Medical Device Product Code "DHB"
(System, Test, Radioallergosorbent (Rast) Immunological)

FDA 510(k) Number Applicant Device Name Decision Date
K863794 3M COMPANY 3M IGG4 FAST TEST PACKAGE 12/03/1986
K897145 3M COMPANY 3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8) 01/10/1990
K864104 3M COMPANY ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST 02/12/1987
K870152 3M COMPANY ALLERGEN SPECIFIC CONTROLS 02/06/1987
K870153 3M COMPANY ALLERGEN SPECIFIC IGG4 CONTROL SERA 02/12/1987
K883273 3M COMPANY DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) 09/07/1988
K885065 3M COMPANY IGE FASTSCREEN S6 (F1, F2, F4, F13, F14) 01/04/1989
K874446 3M COMPANY MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) 12/30/1987
K880002 3M COMPANY MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) 02/17/1988
K880001 3M COMPANY MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 02/25/1988
K883371 3M COMPANY MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) 10/27/1988
K863967 3M COMPANY SPECIFIC IGE FAST(TM) TEST II 12/22/1986
K873998 3M COMPANY TOTAL IGE FAST (TM) TEST PACKAGE 11/04/1987
K913892 3M DIAGNOSTIC SYSTEMS, INC. FASTTECH SYSTEM II 10/02/1991
K913150 ABBOTT LABORATORIES ABBOTT MATRIX AERO PLUS SYSTEM 11/29/1991
K874802 ALERCHEK, INC. FLIPSCREEN QAT 02/17/1988
K860027 ALERCHEK, INC. FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY 04/22/1986
K851512 ALLERGENETICS ALLERGENETICS IGE FAST TEST 05/28/1985
K833418 ALLERGENETICS CHYMOFAST TEST 03/12/1984
K863394 ALLERTEC, INC. RAPID SPECIFIC IGE PROCEDURE 12/03/1986
K953780 BIO-RAD LABORATORIES, INC. ACCESS ALLERGEN DOG EPITHELIM 11/14/1995
K950629 BIO-RAD LABORATORIES, INC. ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR 05/23/1995
K935876 BIO-RAD LABORATORIES, INC. ACCESS SPECIFIC IGE ASSAY 03/11/1994
K896902 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST R IGE 01/10/1990
K903637 CIBA CORNING DIAGNOSTICS CORP. ALRGN SET 11/21/1990
K923420 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY 02/23/1993
K896592 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY 12/04/1989
K884185 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY 10/27/1988
K905054 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER 03/22/1991
K912582 CIBA CORNING DIAGNOSTICS CORP. MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM 07/31/1991
K914959 CIBA CORNING DIAGNOSTICS CORP. MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM 08/20/1992
K885269 DEXALL BIOMEDICAL LABS, INC. ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS 02/07/1989
K875066 DEXALL BIOMEDICAL LABS, INC. ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT 01/29/1988
K864696 DEXALL BIOMEDICAL LABS, INC. ALLERG*ENS ENZYME IMMUNOASSAY KIT 03/17/1987
K884883 DIAGNOSTIC PRODUCTS CORP. 28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM) 01/23/1989
K903742 DIAGNOSTIC PRODUCTS CORP. ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE 10/15/1990
K902576 DIAGNOSTIC PRODUCTS CORP. ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA 09/04/1990
K953014 DIAGNOSTIC PRODUCTS CORP. ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN 08/15/1995
K983954 DIAGNOSTIC PRODUCTS CORP. ALASTAT MICROPLATE MIXED ALLERGEN PANELS 12/17/1998
K935488 DIAGNOSTIC PRODUCTS CORP. ALATOP(R) MICROPLATE ALLERGY SCREEN 03/22/1994
K875244 DIAGNOSTIC PRODUCTS CORP. ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM 04/21/1988
K894227 DIAGNOSTIC PRODUCTS CORP. ALLERGEN MODULES FOR ALASTAT TM 04/17/1991
K912294 DIAGNOSTIC PRODUCTS CORP. ALLERGY INFORMATION MANAGER 11/22/1991
K880160 DIAGNOSTIC PRODUCTS CORP. DPC'S ALLERGEN-SPECIFIC IGE SYSTEM 04/21/1988
K943768 DIAGNOSTIC PRODUCTS CORP. HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT 03/06/1995
K023152 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 ALLERGEN-SPECIFIC IGE 12/17/2002
K013134 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) 10/15/2001
K021208 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 MIXED ALLERGEN PANELS 05/30/2002
K021206 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 SPECIFIC ALLERGENS 05/30/2002
K941564 DIAGNOSTIC PRODUCTS CORP. IMMULITE ALATOP ALLERGY SCREEN 12/19/1994
K973186 DIAGNOSTIC PRODUCTS CORP. IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE 09/29/1997
K963245 DIAGNOSTIC PRODUCTS CORP. IMMULITE LATEX-SPECIFIC IGE 11/18/1996
K013135 DIAGNOSTIC PRODUCTS CORP. IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) 10/19/2001
K931746 DIAGNOSTIC PRODUCTS CORP. LATEX (K82) 03/21/1995
K884923 DIAGNOSTIC PRODUCTS CORP. MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM) 01/11/1989
K961889 DIAGNOSTIC PRODUCTS CORP. SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS 10/10/1996
K910075 DIAGNOSTIC PRODUCTS CORP. SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE 01/30/1991
K883616 DIAGNOSTIC PRODUCTS CORP. SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) 09/22/1988
K881899 DIAGNOSTIC PRODUCTS CORP. SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. 08/10/1988
K954566 DIAGNOSTIC PRODUCTS CORP. SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM 12/18/1995
K843302 DIAGNOSTIC REAGENT TECH. NEW ALLERG. COATED MICROFILTER WELL STRI 10/04/1984
K832344 DIAGNOSTIC REAGENT TECH. POLYSTYRENE MICROTITER PLATE IMMUNO- 11/21/1983
K880003 EM DIAGNOSTIC SYSTEMS, INC. ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST 03/11/1988
K834598 HEMOGENETICS, INC. LIGHT TEST 02/10/1984
K112910 HITACHI CHEMICAL DIAGNOSTICS, INC. AP 72OS SEMI-AUTOMATED INSTRUMENT 12/20/2012
K030590 HITACHI CHEMICAL DIAGNOSTICS, INC. CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) 03/21/2003
K051677 HITACHI CHEMICAL DIAGNOSTICS, INC. OPTIGEN ALLERGEN SPECIFIC IGE ASSAY 01/23/2006
K923284 HYCOR BIOMEDICAL, INC. BASELINE CALIBRATION VERIFICATION CONTROLS 09/28/1992
K080322 HYCOR BIOMEDICAL, INC. HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 03/05/2008
K941278 HYCOR BIOMEDICAL, INC. HY-TEC AUTOMATED EIA SYSTEM 03/13/1995
K081217 HYCOR BIOMEDICAL, INC. HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM 05/22/2008
K965094 HYCOR BIOMEDICAL, INC. HYCOR ALLERGEN DISC 05/21/1997
K945748 HYCOR BIOMEDICAL, INC. HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY 06/07/1995
K925425 HYCOR BIOMEDICAL, INC. SPECIFIC IGE EIA-TURBO ASSAY 01/14/1993
K941057 HYCOR BIOMEDICAL, INC. SPECIFIC IGE EIA-ULTRA ASSAY 01/20/1995
K945884 HYCOR BIOMEDICAL, INC. SPECIFIC IGE ULTRA-EIA 06/30/1995
K922538 HYCOR BIOMEDICAL, INC. VENTREX ALLERGEN DISC 07/27/1992
K924044 HYCOR BIOMEDICAL, INC. VENTREX ALLERGEN DISC 12/01/1992
K924209 HYCOR BIOMEDICAL, INC. VENTREX ALLERGEN DISC 11/30/1992
K921574 HYCOR BIOMEDICAL, INC. WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC 08/03/1992
K020387 IMMUNETECH CORPORATION MYALLERGYTEST SYSTEM 04/17/2002
K863743 IMMUNO NUCLEAR CORP. BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT 12/15/1986
K862265 IMMUNO NUCLEAR CORP. COTTONWOOD ALLERGEN DISC 08/15/1986
K863973 IMMUNO NUCLEAR CORP. ELM ALLERGEN DISC 12/01/1986
K862264 IMMUNO NUCLEAR CORP. ENGLISH PLAINTAIN ALLERGEN DISC 07/03/1986
K863123 IMMUNO NUCLEAR CORP. IMMUNO BIOTECH MUGWART ALLERGEN DISC 10/01/1986
K863844 IMMUNO NUCLEAR CORP. IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC 10/29/1986
K862938 IMMUNO NUCLEAR CORP. JUNE GRASS ALLERGEN DISC 08/15/1986
K862266 IMMUNO NUCLEAR CORP. MAPLE ALLERGEN DISC 08/19/1986
K863098 IMMUNO NUCLEAR CORP. MEADOW FESCUE ALLERGEN DISC 09/15/1986
K862939 IMMUNO NUCLEAR CORP. ORCHARD GRASS ALLERGEN DISC 08/15/1986
K862173 IMMUNO NUCLEAR CORP. PERENNIAL RYE ALLERGEN DISC 07/03/1986
K862176 IMMUNO NUCLEAR CORP. RUSSIAN THISTLE ALLERGEN DISC 08/15/1986
K854756 IMMUNO NUCLEAR CORP. SHORT RAGWEED ALLERGEN DISC 05/15/1986
K862175 IMMUNO NUCLEAR CORP. WHITE OAK ALLERGEN DISC 06/20/1986
K914685 IN VITRO TECHNOLOGIES, INC. 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS 09/14/1992
K875329 IN VITRO TECHNOLOGIES, INC. IVT CENTRAL ALLERGY SCREEN 04/07/1988
K874169 IN VITRO TECHNOLOGIES, INC. IVT NORTHEAST ALLERGY SCREEN 01/11/1988
K904661 IN VITRO TECHNOLOGIES, INC. IVT RAST TRACER 11/29/1990
K874168 IN VITRO TECHNOLOGIES, INC. IVT SOUTHEAST ALLERGY SCREEN 01/11/1988
K870625 IN VITRO TECHNOLOGIES, INC. IVT SOUTHWEST ALLERGY SCREEN 05/01/1987
K875328 IN VITRO TECHNOLOGIES, INC. IVT WESTERN ALLERGY SCREEN 03/23/1988
K871684 INCSTAR CORP. ALTERNARIA TENUIS ALLERGEN DISC 07/16/1987
K873648 INCSTAR CORP. BAHIA ALLERGEN DISC 10/08/1987
K873770 INCSTAR CORP. BERMUDA GRASS ALLERGEN DISC 10/20/1987
K870264 INCSTAR CORP. CAT EPITHELIUM ALLERGEN DISC 02/13/1987
K870597 INCSTAR CORP. D. FARINAE ALLERGEN DISC 03/04/1987
K874149 INCSTAR CORP. FALSE RAGWEED ALLERGEN DISC 11/04/1987
K873969 INCSTAR CORP. GIANT RAGWEED ALLERGEN DISC 11/04/1987
K875163 INCSTAR CORP. GOLDENROD ALLERGEN DISC 04/21/1988
K875110 INCSTAR CORP. HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC 06/14/1988
K873676 INCSTAR CORP. IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT 10/07/1987
K873814 INCSTAR CORP. IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST 10/20/1987
K880168 INCSTAR CORP. INCSTAR'S BIRCH ALLERGEN DISC 05/11/1988
K880187 INCSTAR CORP. INCSTAR'S DANDELION ALLERGEN DISC 04/21/1988
K880221 INCSTAR CORP. INCSTAR'S PIGWEED ALLERGEN DISC 05/11/1988
K874150 INCSTAR CORP. JOHNSON GRASS ALLERGEN DISC 11/04/1987
K874440 INCSTAR CORP. LIVE OAK ALLERGEN DISC 11/25/1987
K874540 INCSTAR CORP. MARSH ELDER ALLERGEN DISC 05/11/1988
K880415 INCSTAR CORP. MESQUITE ALLERGEN DISC 04/21/1988
K873486 INCSTAR CORP. RED TOP ALLERGEN DISC 10/07/1987
K873406 INCSTAR CORP. RRT SHORT RAGWEED TEST KIT 09/23/1987
K871723 INCSTAR CORP. SWEET VERNAL ALLERGEN DISC 07/13/1987
K875274 INCSTAR CORP. TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) 02/17/1988
K874883 INCSTAR CORP. WALNUT ALLERGEN DISC 05/11/1988
K871660 INCSTAR CORP. WESTERN RAGWEED ALLERGEN DISC 05/14/1987
K880567 INCSTAR CORP. WHITE ASH ALLERGEN DISC 04/21/1988
K883537 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CONTROL E 11/04/1988
K823470 KALLESTAD LABORATORIES, INC. ALLERCOAT ALLERGEN DISCS 12/15/1982
K852794 KALLESTAD LABORATORIES, INC. ALLERCOAT ALLERGEN DISCS 09/19/1985
K840360 KALLESTAD LABORATORIES, INC. ALLERCOAT MULTISCREEN DISCS 03/09/1984
K812414 KALLESTAD LABORATORIES, INC. KALLESTAD 125I ANTISERUM TO HUMAN IGE 09/14/1981
K820029 KALLESTAD LABORATORIES, INC. KALLESTAD RAST REAGENTS 04/06/1982
K871599 LKB INSTRUMENTS, INC. DELFIA(TM) HIGE KIT 06/12/1987
K914850 MAST IMMUNOSYSTEMS CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE 12/09/1991
K823593 MAST IMMUNOSYSTEMS INHALANT PROFILE-ALLERGEN-SPECIFIC IGE 02/25/1983
K843694 MAST IMMUNOSYSTEMS MAST ALLERGY SYSTEM 04/12/1985
K910292 MAST IMMUNOSYSTEMS MAST CLA ALLERGY SYSTEM 04/05/1991
K926420 MAST IMMUNOSYSTEMS MAST CLA ALLERGY SYSTEM 03/07/1994
K934524 MAST IMMUNOSYSTEMS MAST CLA ALLERGY SYSTEM 03/07/1994
K833885 MAST IMMUNOSYSTEMS MAST INHALANT PROFILE 01/04/1984
K834526 MAST IMMUNOSYSTEMS MAST INHALANT PROFILE 04/04/1984
K844629 MAST IMMUNOSYSTEMS MAST LUMINESCENT ALLERGY SYSTEM 04/12/1985
K870966 MAST IMMUNOSYSTEMS TOTAL IGE MASTICK 04/14/1987
K874281 MEDIX BIOTECH, INC. MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT 12/18/1987
K121156 PHADIA AB AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES 03/13/2013
K092050 PHADIA AB IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 11/20/2009
K101251 PHADIA AB IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN 05/27/2011
K150597 PHADIA AB ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite 02/29/2016
K100999 PHADIA AB IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 12/15/2010
K071913 PHADIA AB IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 08/24/2007
K123275 PHADIA AB IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM 06/28/2013
K163370 PHADIA AB ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE 05/05/2017
K081830 PHADIA AB IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 03/16/2009
K131738 PHADIA AB IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H 07/10/2013
K173726 Phadia AB ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut 04/16/2018
K150854 PHADIA AB ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut 12/14/2015
K151029 PHADIA AB Phadia Prime 01/19/2016
K122197 PHADIA US INC. AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES 08/28/2013
K113841 PHADIA US INC. IMMUNOCAP ALLERGEN COMPONENTS BUNDLE 09/13/2012
K092978 PHADIA US INC. IMMUNOCAP RAPID READER, MODEL 12-3600-10 01/19/2010
K111919 PHADIA US INC. IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS 12/22/2011
K993388 PHARMACIA & UPJOHN CO. ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F 12/01/1999
K974580 PHARMACIA & UPJOHN CO. ALLERGEN IMMUNOCAP F256,F245,F207,F202 02/09/1998
K982343 PHARMACIA & UPJOHN CO. ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 09/15/1998
K000132 PHARMACIA & UPJOHN CO. ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 02/18/2000
K991048 PHARMACIA & UPJOHN CO. ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 05/14/1999
K962976 PHARMACIA & UPJOHN CO. PHARMACIA CAP SYSTEM RAST FEIA 12/23/1996
K051218 PHARMACIA DIAGNOSTICS AB MODIFICATION TO: UNICAP SPECIFIC IGE 06/09/2005
K974350 PHARMACIA, INC. ALLERGAN IMMUNO CAP M4, M8, K70 02/09/1998
K911903 PHARMACIA, INC. ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA 08/12/1991
K910517 PHARMACIA, INC. CAP SYSTEM RAST ASM/RIA AND ASM/FEIA 03/05/1991
K872280 PHARMACIA, INC. MODIFIED PHADEBAS RAST/PHADEZYM RAST 10/07/1987
K830155 PHARMACIA, INC. PHADEBAS & PHADEZYM RAST ALLERGEN DISCS 03/10/1983
K831442 PHARMACIA, INC. PHADEBAS & PHADEZYM RAST ALLERGEN DISCS 06/08/1983
K831045 PHARMACIA, INC. PHADEBAS & PHADEZYM RAST MIXED ALLERG 04/27/1983
K823592 PHARMACIA, INC. PHADEBAS & PHADEZYM RAST TEST ALLERG 03/24/1983
K830096 PHARMACIA, INC. PHADEBAS & PHADEZYME RAST ALLERGEN DISC 01/28/1983
K771578 PHARMACIA, INC. PHADEBAS RAST PENICLLOYL G/V TEST 09/02/1977
K840670 PHARMACIA, INC. PHADEBAS RAST PHADEZYM MIX ALLERG 04/18/1984
K851273 PHARMACIA, INC. PHADEBAS RAST PHADEZYM RAST ALLERTUBES 05/21/1985
K854865 PHARMACIA, INC. PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5 04/22/1986
K802556 PHARMACIA, INC. PHADEBAS RAST TEST 12/02/1980
K822141 PHARMACIA, INC. PHADEBAS RAST TEST 08/03/1982
K840876 PHARMACIA, INC. PHADEBAS RAST TEST -ALLERGEN DISCS 04/17/1984
K852189 PHARMACIA, INC. PHADEBAS RAST TEST ALLERGEN DISCS 07/15/1985
K853969 PHARMACIA, INC. PHADEBAS RAST TEST ALLERGEN DISCS 11/18/1985
K893132 PHARMACIA, INC. PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC 06/02/1989
K872946 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC 10/20/1987
K873112 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC 10/20/1987
K873193 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS 10/08/1987
K845032 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS 03/21/1985
K863036 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERTUBE 10/03/1986
K852263 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERTUBES 06/27/1985
K853456 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERTUBES 09/19/1985
K854939 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST ALLERTUBES 02/13/1986
K861184 PHARMACIA, INC. PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS 04/25/1986
K842457 PHARMACIA, INC. PHADEXACT SERUM, ALLERGEN SPECIFIC IGE 07/02/1984
K810462 PHARMACIA, INC. PHADEZYM RAST TEST 03/11/1981
K891135 PHARMACIA, INC. PHADIATOP PAEDIATRIC RIA AND EIA 05/09/1989
K863355 PHARMACIA, INC. PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA 09/17/1986
K941993 PHARMACIA, INC. PHARMACIA CAP SYSTEM PHADIATOP FEIA 01/30/1996
K894190 PHARMACIA, INC. PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA 01/22/1990
K880899 PHARMACIA, INC. PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA 05/16/1988
K840537 PHARMACIA, INC. RAST ALLERGO SORBENT TEST 04/02/1984
K962274 PHARMACIA, INC. UNICAP 100 09/12/1996
K972364 PHARMACIA, INC. UNICAP PHADIATOP 09/04/1997
K972068 PHARMACIA, INC. UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 07/03/1997
K875125 PROGENE CORP. PROGENE(TM) IGE TEST 02/25/1988
K905176 QUIDEL CORP. POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN 12/13/1990
K950728 QUIDEL CORP. QUICKVUE ONE-STEP ALLERGEN SCREEN 10/02/1995
K883666 QUIDEL CORP. QUIDEL ALLERGY SCREEN 10/18/1988
K874717 QUIDEL CORP. QUIDEL ALLERGY SCREEN 04/06/1988
K894253 QUIDEL CORP. QUIDEL FOOD ALLERGEN SCREEN 07/28/1989
K892409 QUIDEL CORP. QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN 05/04/1989
K884501 QUIDEL CORP. QUIDEL FOOD ALLERGY SCREEN 02/17/1989
K905162 QUIDEL CORP. QUIDEL TOTAL IGE POSITIVE CONTROL SERUM 01/14/1991
K875168 QUIDEL CORP. QUIDEL TOTAL IGE TEST 03/18/1988
K101572 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 08/01/2011
K083314 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 03/11/2009
K083853 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 03/24/2009
K090257 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 05/26/2009
K091289 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 08/06/2009
K093107 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 09/30/2010
K093987 Siemens Healthcare Diagnostics Inc. IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 03/28/2011
K112523 Siemens Healthcare Diagnostics Inc. IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT 01/06/2012
K132801 Siemens Healthcare Diagnostics Inc. IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY 05/28/2014
K100910 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 05/11/2011
K091984 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 10/28/2009
K121463 Thermo Fisher Scientific IMMUNOCAP ALLERGEN K82 01/29/2013
K831554 VENTREX LABORATORIES, INC. NEIN ALLERGEN DISC IN VAST VENTREX TEST 06/08/1983
K831091 VENTREX LABORATORIES, INC. NEW ALLERGEN DISC -VAST VENTEX ALLERGY 04/27/1983
K830170 VENTREX LABORATORIES, INC. RIASSIST RAST DATA REDUCTION/QUALITY 02/07/1983
K914554 VENTREX LABORATORIES, INC. SPECIFIC IGE EIA-TURBO ASSAY 03/13/1992
K904330 VENTREX LABORATORIES, INC. TURBO-RAST SPECIFIC IGE ASSAY 12/07/1990
K821451 VENTREX LABORATORIES, INC. VAST VENTREX ALLERGY SYSTEMS TESTS 06/23/1982
K832217 VENTREX LABORATORIES, INC. VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD 09/20/1983
K871331 VENTREX LABORATORIES, INC. VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. 04/28/1987
K862901 VENTREX LABORATORIES, INC. VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY 09/16/1986
K870009 VENTREX LABORATORIES, INC. VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM. 04/14/1987
K841516 VENTREX LABORATORIES, INC. VENTRESCREEN, MULTIPLE ALLERGEN DISCS 05/11/1984
K913833 VENTREX LABORATORIES, INC. VENTREX ALLERGEN DISC 02/21/1992
K896852 VENTREX LABORATORIES, INC. VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY 12/18/1989
K905636 VENTREX LABORATORIES, INC. VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY 02/07/1991
K870624 VENTREX LABORATORIES, INC. VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY 03/24/1987
K880547 VENTREX LABORATORIES, INC. VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY 03/25/1988
K896694 VENTREX LABORATORIES, INC. VENTREZYME VAST SPECIFIC IGE ASSAY 12/08/1989
K850895 VENTREX LABORATORIES, INC. VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY 10/16/1985
K924119 VENTREX, INC. VENTREX ALLERGEN DISC 11/30/1992
K925044 VENTREX, INC. VENTREX ALLERGEN DISC 05/14/1993
K855053 VISUAL DIAGNOSTICS, INC. THABEST-IGE 04/22/1986
K913212 WHITTAKER BIOPRODUCTS, INC. 3M IGE SINGLE POINT FAST TEST 11/22/1991


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact